European Archives of Oto-Rhino-Laryngology最新文献

{"title":"Reliability, validity and normative data of the timed water swallow test accompanied by sEMG.","authors":"Dilan Selen Akıl, Serkan Bengisu, Eyüp Sezer, Yakup Krespi, Saime Seyhun Topbaş","doi":"10.1007/s00405-024-08884-7","DOIUrl":"10.1007/s00405-024-08884-7","url":null,"abstract":"<p><strong>Purpose: </strong>Swallowing disorders are highly interrelated with increased morbidity and mortality rates; therefore, early detection is crucial. Most screening tools rely on subjective observation, thus making objective assessment tools more vital. Timed Water Swallowing Test (TWST) is a screening tool used in the field providing quantitative data. This study aimed to investigate the swallowing parameters in a wide age range by using TWST and to expand the already existing normative data pool accordingly. It is also aimed to examine the reliability of the TWST and assess its validity in stroke survivors.</p><p><strong>Materials and methods: </strong>This study had a cross-sectional design. TWST carried out simultaneously along with surface EMG and laryngeal sensor on 196 healthy subjects aged 10 to 80 for normative data. Also, TWST carried out 30 patients having a history of recent stroke. Test-retest and inter-rater scoring analysis were used for reliability purposes, while Gugging Swallowing Screen (GUSS) test was used for validity purposes. Additionally, the correlations between the participants' TWST scores and GUSS scores were examined using the Spearman correlation coefficient.</p><p><strong>Results: </strong>The normative TWST data of healthy participants are tabulated and presented and their average swallowing capacity was found 13.73 ml/s. Furthermore, the mean swallowing capacity of stroke survivors was found 4.61 ml/s. As a result of validity analyses, a statistically strong and significant relationship was found between GUSS and TWST parameters (r = 0.775, p < 0.001). Intraclass correlation coefficient (ICC) and correlation values were found between moderate to good agreement between test-retest measurement (ICC = 0.563 to 0.891, p < 0.05). Also, the agreement between the raters was found to be significant (ICC = 0.949 to 0.995, p < 0.05).</p><p><strong>Conclusion: </strong>TWST is a valid and reliable screening tool to evaluate dysphagia on given population. Although the test's performance on healthy individuals is adequate, more research is still needed to confirm that it can be used as a screening tool for stroke.</p>","PeriodicalId":11952,"journal":{"name":"European Archives of Oto-Rhino-Laryngology","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11512847/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141897157","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A cross-sectional survey assessing clinicians' perspectives towards redesigning the surveillance model for head and neck cancer: can we do better?","authors":"Grace Maina, Fiona Crawford-Williams, Charmaine Woods, Eng H Ooi","doi":"10.1007/s00405-024-08791-x","DOIUrl":"10.1007/s00405-024-08791-x","url":null,"abstract":"<p><strong>Background: </strong>Service delivery of post-treatment surveillance in head and neck cancer (HNC) varies across institutions in Australia. To better understand current practices and develop protocols that maximize service capacity or incorporate emerging technologies, especially in under-resourced regional and remote communities, it is important to obtain the perspectives of clinicians that regularly manage patients with HNC.</p><p><strong>Design: </strong>This cross-sectional study utilized an online survey distributed via email to specialists recruited from HNC-associated networks across Australia. The survey captured information on current practices and explored clinician perspectives towards re-designing the current surveillance model to incorporate telehealth or patient-reported outcome measures (PROMs). Quantitative data was analyzed using descriptive statistics while open-ended survey comments were analyzed using a content analysis approach.</p><p><strong>Results: </strong>Forty participants completed the survey (25 surgeons, 9 medical oncologists, 5 radiation oncologists and 1 oral medicine specialist). Most clinicians used either institution-specific guidelines (44%) or National Comprehensive Cancer Network guidelines (39%), with the remaining 17% using surveillance intervals based on patient symptoms. Following treatment, 53% of participants imaged patients only when there was clinical suspicion of recurrence or new symptoms. Planned surveillance imaging was conducted at 6 or 12-monthly intervals based on the HNC subtype. Fifty-seven percent of clinicians were open to redesigning the surveillance model, specifically in low-risk patients who did not require nasoendoscopic examination. Seventy-one percent had concerns regarding the feasibility of telehealth appointments, citing disparities in digital health equity. Additionally, 61% felt PROMs are currently underutilized and were open to incorporating HNC-specific PROMS into surveillance. Open-ended responses indicated that within the current surveillance model, \"fragmented service provision\" and \"administration issues\" were significantly impacting on timing of care.</p><p><strong>Conclusion: </strong>Surveyed HNC clinicians feel that current post-treatment surveillance can be fragmented and potentially lead to delayed care. They are open to incorporating PROMS to assist in surveillance scheduling, especially in low-risk patients.</p>","PeriodicalId":11952,"journal":{"name":"European Archives of Oto-Rhino-Laryngology","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141563052","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy of chemoradiotherapy in elderly patients with stage IV inoperable head and neck cancer.","authors":"Runqiu Zhu, Pan Wang, Jiahui Dai, Yangxi Cheng, Huiyong Zhu","doi":"10.1007/s00405-024-08805-8","DOIUrl":"10.1007/s00405-024-08805-8","url":null,"abstract":"<p><strong>Objectives: </strong>This study aimed to compare the efficacy of chemoradiotherapy (CRT) with radiotherapy (RT) alone for elderly patients (≥ 65 years) with stage IV inoperable head and neck cancer (IV-HNC).</p><p><strong>Methods: </strong>Elderly patients diagnosed with inoperable IV-HNC from 2010 to 2015 were identified using the SEER database. Then, we performed a 1:1 propensity-score matched (PSM) analysis to reduce treatment selection bias, and the prognostic role of CRT was investigated using Kaplan-Meier analysis, log-rank test, and Cox proportional hazard models. The main outcome was overall survival (OS), and the secondary outcome was cancer-specific survival (CSS).</p><p><strong>Results: </strong>A total of 3318 patients were enrolled, of whom 601 received RT alone and 2717 received CRT. Through PSM, 526 patients were successfully matched, and balances between the two treatment groups were reached. In the matched dataset, multivariable Cox analysis revealed that CRT was associated with better OS (HR = 0.580, P < 0.001) and CSS (HR = 0.586, P < 0.001). Meanwhile, subgroups of patients with IV-HNC (younger age, male sex, being married, black race, grade I-II, oral cavity site, T3-T4 stage, N0-N1 stage, M1 stage) were inclined to benefit more from CRT treatment. Furthermore, the survival benefit of CRT was more pronounced in patients aged 65 to 80 years, but was absent in patients aged 80 years or older.</p><p><strong>Conclusions: </strong>This study indicated that CRT resulted in better survival than RT alone in elderly patients with inoperable IV-HNC, especially for those subpopulations that benefit more from CRT treatment.</p>","PeriodicalId":11952,"journal":{"name":"European Archives of Oto-Rhino-Laryngology","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141747768","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Nasolacrimal duct rhinostomy for low-level nasolacrimal duct obstruction:long-term outcomes and surgical selection paradigm.","authors":"Kerui Wang, Xinyue Yu, Jing Li, Ziwei Meng, Yu Hu, Xinyu Zheng, Can Yang, Xuanwei Liang, Rongxin Chen, Zuohong Li","doi":"10.1007/s00405-024-08797-5","DOIUrl":"10.1007/s00405-024-08797-5","url":null,"abstract":"<p><strong>Propose: </strong>This study aims to present long-term outcomes in a specific patient population experiencing epiphora due to low-level nasolacrimal duct obstruction (NLDO) following endonasal endoscopic nasolacrimal duct rhinostomy, and to propose a surgical selection paradigm for varying locations of NLDO.</p><p><strong>Methods: </strong>Between September 1, 2017 and February 28, 2023, a retrospective analysis was conducted on 26 patients diagnosed with primary acquired nasolacrimal duct obstruction (PANDO) who underwent endonasal endoscopic nasolacrimal duct rhinostomy for low-level NLDO (defined as obstruction below the plane of the superior border of the inferior turbinate attachment). The study assessed surgical success through objective measures of anatomical patency and subjective measures of functional patency during a postoperative follow-up period of at least six months. Additionally, any complications that arose during this follow-up period were documented.</p><p><strong>Results: </strong>The study included a cohort of 26 patients, consisting of 24 women and 2 men, with a mean age of 47.58 ± 3.09 years (range: 8-75). All patients underwent endoscopic nasolacrimal duct rhinostomy, with 10 eyes having previously undergone tear duct recanalization procedures. Anatomical patency was achieved in 88.5% (23/26) of cases, while functional patency was achieved in 80.8% (21/26) after an average follow-up period of 41.9 ± 22.1 months. No significant complications were observed in any of the patients during the follow-up period.</p><p><strong>Conclusion: </strong>Endonasal endoscopic nasolacrimal duct rhinostomy is effective in treating epiphora in over 80% of cases with low-level NLDO. Tailoring the surgery to the location of the obstruction can improve outcomes and minimize damage.</p>","PeriodicalId":11952,"journal":{"name":"European Archives of Oto-Rhino-Laryngology","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141897155","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An innovative reconstruction procedure for fractures extending to the posterior orbital floor: utilizing the inferior margin of the greater wing of the sphenoid bone for reconstruction.","authors":"Kosuke Takabayashi, Yohei Maeda, Nobuya Kataoka","doi":"10.1007/s00405-024-08808-5","DOIUrl":"10.1007/s00405-024-08808-5","url":null,"abstract":"<p><strong>Purpose: </strong>No definitive procedures have been proposed for orbital floor fractures extending to the slope of the posterior end, which is a challenging problem. This study demonstrates the effectiveness of an orbital reconstruction procedure based on anatomical landmarks that we developed, called the three landmarks procedure (TLP).</p><p><strong>Methods: </strong>This study is a single-center retrospective cohort study conducted by the Department of Otorhinolaryngology, Japanese Red Cross Asahikawa Hospital. Data were collected from April 2000 to December 2023. The effect of TLP and the balloon procedure (BP) on ocular movement was compared. The prevalence of postoperative enophthalmos after TLP was examined.</p><p><strong>Results: </strong>The study included 17 patients who underwent TLP and 25 patients who underwent BP. Postoperative mean Hess area ratio (HAR%) was 98.3 (95% confidence interval (CI), 97.0-99.6) in the TLP group and 88.6 (95% CI 83.2-94.0) in the BP group. Among study patients with fractures extending to the posterior slope, 14 underwent TLP and 16 underwent BP. Postoperative mean HAR% was 98.5 (95% CI 97.3-99.7) in the TLP group and 89.2 (95% CI 82.4-95.8) in the BP group. Among all patients who underwent TLP, mean postoperative enophthalmos was 0.06 mm (95% CI - 0.32 to 0.44). It was 0.14 mm (95% CI - 0.31 to 0.59) among patients with fractures extending to the posterior slope.</p><p><strong>Conclusion: </strong>TLP resulted in better postoperative ocular movements than BP. Furthermore, TLP is an effective technique for treating fractures extending to the posterior slope, which are challenging to reconstruct.</p>","PeriodicalId":11952,"journal":{"name":"European Archives of Oto-Rhino-Laryngology","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11512830/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141859421","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Swallowing outcomes after tracheal resection and anastomosis: full versus mini infrahyoid laryngeal drop.","authors":"Ahmed Abdel-Fattah ElSobki, Noha Ahmed El-Kholy, Eslam Hamed Elsayed Abdou, Reham A E Ibrahim, Ayman Amer, Mohamed El-Deeb, Mahmoud Elsaid Ibrahim Alsobky, Ahmed Negm","doi":"10.1007/s00405-024-08904-6","DOIUrl":"10.1007/s00405-024-08904-6","url":null,"abstract":"<p><strong>Introduction: </strong>Tracheal resection anastomosis has been established as the definitive surgery for high grade postintubation subglottic stenosis. To achieve a relaxed tension-free anastomosis, various laryngeal release techniques were discussed in literature with potential effect on postoperative swallowing dysfunction. This study aims to compare the difference in swallowing outcomes following two methods of infrahyoid laryngeal release: with and without fracture of the superior thyroid horns.</p><p><strong>Methods: </strong>A retrospective cohort study was carried out at our tertiary referral hospitals including cases with grade III and IV subglottic stenosis treated by partial crico-tracheal resection with thyro-tracheal anastomosis. The patients were divided into two groups according to the method used in laryngeal release; mini infrahyoid release (group A) or infrahyoid full release (group B) where full means with fracture of the superior thyroid horn bilaterally while mini means their preservation. Swallowing assessment preoperatively and postoperatively was done by comparing swallowing dysfunction symptoms, Gugging swallowing screen (GUSS) score and fiberoptic endoscopic evaluation of swallowing (FEES) according to penetration aspiration scale (PAS).</p><p><strong>Results: </strong>A total of 71 patients were included; 46 in Group A and 25 in Group B. Clinical swallowing evaluation one week postoperatively showed statistically significant difference between the two groups being affected in 80.04% and 100% of patients in group A and B, respectively. The mean postoperative GUSS were 18 ± 1.32 in group A patients in comparison to 8.84 ± 5.18 in group B (p-value < 0.001). With FEES assessment, group A had full improvement of their swallowing abilities one month after the surgery while patients in group B had significantly lower PAS scores. Unfavourable scores for both the GUSS test and PAS were associated with increasing patients' age in group B.</p><p><strong>Conclusion: </strong>In this retrospective cohort study, cases with mini infrahyoid laryngeal release had significantly better swallowing outcomes and full resolution of dysphagia in comparison to full laryngeal release. Also, full laryngeal release is associated with delayed resolution of swallowing difficulty in older patients. This point should be considered during preoperative patient selection and counselling.</p>","PeriodicalId":11952,"journal":{"name":"European Archives of Oto-Rhino-Laryngology","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11512918/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142105707","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exclusive endoscopic tympanoplasty efficacy in the treatment of cholesteatoma without mastoid involvement.","authors":"Luca Bianconi, Stefano Meneghesso, Valerio Arietti, Giacomo Leonardi, Daniele Monzani, Luca Sacchetto","doi":"10.1007/s00405-024-08778-8","DOIUrl":"10.1007/s00405-024-08778-8","url":null,"abstract":"<p><strong>Purpose: </strong>The purpose of this study is to determine the recurrence rate of cholesteatoma in patients who have undergone exclusive endoscopic tympanoplasty at our tertiary referral institution. A secondary objective is to analyze different clinical aspects that could be considered risk factors for recurrence to establish if it is possible to determine when a second-look procedure is indicated instead of a clinical follow-up.</p><p><strong>Methods: </strong>A retrospective study was performed on patients who had undergone exclusive endoscopic tympanoplasty for cholesteatoma in the last eight years and who were followed up for at least one year. The efficacy of the treatment performed only with the exclusive endoscopic technique was analyzed. Then, the anamnestic and intraoperative data were studied to identify possible factors that could increase the risk of recurrence.</p><p><strong>Results: </strong>The recurrence rate (14.5%) in patients (164) who underwent primary surgery with the exclusive endoscopic technique between January 2014 and January 2022 was similar to that in patients who underwent the microscopic technique with mastoidectomy in literature. In addition, we analyzed several clinical factors such as age, ossicular chain erosion, extension and localization of the cholesteatoma finding that only the last one could potentially be a risk factor for recurrence in this selected population.</p><p><strong>Conclusion: </strong>Exclusive endoscopic tympanoplasty has been shown to be effective in removing cholesteatoma in patients without evidence of mastoid involvement, with recurrence rates comparable to traditional microscopic technique and a minimally invasive approach, even considering the patient's age, ossicular chain erosion and extension of the disease.</p>","PeriodicalId":11952,"journal":{"name":"European Archives of Oto-Rhino-Laryngology","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11512923/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142344089","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The quality and readability of patient information provided by ChatGPT: can AI reliably explain common ENT operations?","authors":"Michel Abou-Abdallah, Talib Dar, Yasamin Mahmudzade, Joshua Michaels, Rishi Talwar, Chrysostomos Tornari","doi":"10.1007/s00405-024-08598-w","DOIUrl":"10.1007/s00405-024-08598-w","url":null,"abstract":"<p><strong>Purpose: </strong>Access to high-quality and comprehensible patient information is crucial. However, information provided by increasingly prevalent Artificial Intelligence tools has not been thoroughly investigated. This study assesses the quality and readability of information from ChatGPT regarding three index ENT operations: tonsillectomy, adenoidectomy, and grommets.</p><p><strong>Methods: </strong>We asked ChatGPT standard and simplified questions. Readability was calculated using Flesch-Kincaid Reading Ease Score (FRES), Flesch-Kincaid Grade Level (FKGL), Gunning Fog Index (GFI) and Simple Measure of Gobbledygook (SMOG) scores. We assessed quality using the DISCERN instrument and compared these with ENT UK patient leaflets.</p><p><strong>Results: </strong>ChatGPT readability was poor, with mean FRES of 38.9 and 55.1 pre- and post-simplification, respectively. Simplified information from ChatGPT was 43.6% more readable (FRES) but scored 11.6% lower for quality. ENT UK patient information readability and quality was consistently higher.</p><p><strong>Conclusions: </strong>ChatGPT can simplify information at the expense of quality, resulting in shorter answers with important omissions. Limitations in knowledge and insight curb its reliability for healthcare information. Patients should use reputable sources from professional organisations alongside clear communication with their clinicians for well-informed consent and making decisions.</p>","PeriodicalId":11952,"journal":{"name":"European Archives of Oto-Rhino-Laryngology","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140293254","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The use of artificial intelligence in reconstructive surgery for head and neck cancer: a systematic review.","authors":"Cyril Devault-Tousignant, Myriam Harvie, Eric Bissada, Apostolos Christopoulos, Paul Tabet, Louis Guertin, Houda Bahig, Tareck Ayad","doi":"10.1007/s00405-024-08663-4","DOIUrl":"10.1007/s00405-024-08663-4","url":null,"abstract":"<p><strong>Objectives: </strong>The popularity of artificial intelligence (AI) in head and neck cancer (HNC) management is increasing, but postoperative complications remain prevalent and are the main factor that impact prognosis after surgery. Hence, recent studies aim to assess new AI models to evaluate their ability to predict free flap complications more effectively than traditional algorithms. This systematic review aims to summarize current evidence on the utilization of AI models to predict complications following reconstructive surgery for HNC.</p><p><strong>Methods: </strong>A combination of MeSH terms and keywords was used to cover the following three subjects: \"HNC,\" \"artificial intelligence,\" and \"free flap or reconstructive surgery.\" The electronic literature search was performed in three relevant databases: Medline (Ovid), Embase (Ovid), and Cochrane. Quality appraisal of the included study was conducted using the TRIPOD Statement.</p><p><strong>Results: </strong>The review included a total of 5 manuscripts (n = 5) for a total of 7524 patients. Across studies, the highest area under the receiver operating characteristic (AUROC) value achieved was 0.824 by the Auto-WEKA model. However, only 20% of reported AUROCs exceeded 0.70. One study concluded that most AI models were comparable or inferior in performance to conventional logistic regression. The highest predictors of complications were flap type, smoking status, tumour location, and age.</p><p><strong>Discussion: </strong>Some models showed promising results. Predictors identified across studies were different than those found in existing literature, showing the added value of AI models. However, the algorithms showed inconsistent results, underlying the need for better-powered studies with larger databases before clinical implementation.</p>","PeriodicalId":11952,"journal":{"name":"European Archives of Oto-Rhino-Laryngology","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140859780","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety and performance of the new med-el total ossicular replacement prostheses.","authors":"Esther Schimanski, Thomas Lenarz, Susan Busch, Susan Arndt, Christian Offergeld, Christoph Arnoldner, Dominik Riss, Joachim Hornung, Lava Taha, Paul Martin Zwittag, Nina Rubicz, Dirk Beutner, Nicholas Bevis, Benjamin Loader, Franz Windisch, Georg Sprinzl, Astrid Magele, Wendelin Wolfram, Lisa Niederwanger, Łukasz Plichta, Piotr H Skarżyński","doi":"10.1007/s00405-024-08784-w","DOIUrl":"10.1007/s00405-024-08784-w","url":null,"abstract":"<p><strong>Purpose: </strong>This multicentric, retrospective study provides safety and performance data of the MED-EL total ossicular replacement prostheses (TORP).</p><p><strong>Methods: </strong>Patients underwent tympanoplasty with mXACT Total Prosthesis Center, mXACT Total Prosthesis Offcenter or mXACT PRO Total Prosthesis. The clinical data were retrospectively analyzed. Follow-up examination included access to the medical record (for adverse events) of the patients, ear microscopy and pure-tone audiometry to determine the post-operative pure tone average of the frequencies 0.5, 1, 2 and 3 kHz (PTA₄). The post-operative PTA₄ air bone gap (ABG) was used to evaluate the audiological outcome. A post-operative minimum and maximum follow-up period was not defined.</p><p><strong>Results: </strong>103 patients were implanted with a TORP. 102 (88 adults, 14 children; 37 CHL, 64 MHL, 1 not specified) patients were analyzed for safety and 92 (79 adults, 13 children) patients for performance of the prostheses. ADVERSE EVENTS RESULTS (N = 102): In 1 patient (child, mXACT Total Prosthesis Offcenter) a prosthesis dislocation was reported, which lead to a revision surgery. No prosthesis extrusion or migration was reported. AUDIOLOGICAL RESULTS (N = 92): 49 (53.3%) of the 92 patients had a PTA₄ ABG of ≤ 20 dB and therefore a successful rehabilitation. The mean post-operative PTA₄ ABG of all 92 patients was 21.0 ± 9.7 dB. The first endpoint, improvement in post-operative PTA₄ ABG of ≤ 20 dB by ≥ 25% of the patients was achieved. The individual Δ BC PTA₄ (post-operative minus pre-operative BC PTA₄) thresholds were stable (within ± 5 dB HL) in 91 (98.9%) patients. 1 patient had a BC PTA₄ deterioration of 11.3 dB HL.</p><p><strong>Conclusion: </strong>The MED-EL TORPs are safe and effective for middle ear reconstruction. Trial registration number NCT05565339, September 09, 2022, retrospectively registered.</p>","PeriodicalId":11952,"journal":{"name":"European Archives of Oto-Rhino-Laryngology","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141603472","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}